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Influence of Stress on Non Surgical Periodontal Treatment

Primary Purpose

Chronic Periodontitis

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Non surgical periodontal treatment
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Periodontitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Severe generalized chronic periodontitis
  • Minimum 15 teeth
  • Attachment loss > 5mm
  • 30% of sites affected- 5% of pockets>5mm
  • Bone loss- Bleeding on probing

Exclusion Criteria:

  • Patient at risk of endocarditis
  • Pregnant women
  • Patient under therapy for depression
  • Patient treated for periodontal diseases previously

Sites / Locations

  • Service de parodontologie

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

questionary

Arm Description

Outcomes

Primary Outcome Measures

Changing depths of periodontal pockets

Secondary Outcome Measures

Full Information

First Posted
June 25, 2013
Last Updated
August 19, 2019
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT02568163
Brief Title
Influence of Stress on Non Surgical Periodontal Treatment
Official Title
Influence of Stress on Non Surgical Periodontal Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Why Stopped
The number of subjects were underestimated, which implies a reduction in the number of subjects required.
Study Start Date
September 2013 (Actual)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Treatment of periodontal diseases is influenced by several risk factors. Psychological stress is considered as one of them. Aim of this study is to assess if stress influences results of non surgical periodontal treatment in severe chronic forms of periodontitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
questionary
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Non surgical periodontal treatment
Primary Outcome Measure Information:
Title
Changing depths of periodontal pockets
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Severe generalized chronic periodontitis Minimum 15 teeth Attachment loss > 5mm 30% of sites affected- 5% of pockets>5mm Bone loss- Bleeding on probing Exclusion Criteria: Patient at risk of endocarditis Pregnant women Patient under therapy for depression Patient treated for periodontal diseases previously
Facility Information:
Facility Name
Service de parodontologie
City
Strasbourg
State/Province
Bas Rhin
ZIP/Postal Code
67000
Country
France

12. IPD Sharing Statement

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Influence of Stress on Non Surgical Periodontal Treatment

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